Registration - Speakers
REGISTER DIVISIONS
The Registration Division consists of three key units: the General and IVD Registration Unit, the Change Notification Unit, and the Classification and Combination Products Unit.
Each unit plays a vital role in evaluating registration applications, managing changes to a registered medical device, and determining product classifications. The division also develops regulatory requirements and procedures, provides technical guidance, and ensures compliance with medical device regulations to safeguard the quality, safety, and performance of medical devices in Malaysia.
